FDA.report

Sterilized Eol Auto Lancet

Primary DI
08809262393880
Brand
Sterilized Eol Auto Lancet
Company
HLB CO.,LTD
Model
LBAL 28G
Published
2025-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications

CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K243533000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243533000Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare2025-01-13FMK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809262393422PrimaryGS10
08809262393880Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809262393422088092623934228809262393422
08809262393880088092623938808809262393880

GMDN Terms

TermDefinition
Fully-implantable middle ear implant system vibrator assemblyA component of a fully-implantable middle ear implant system that includes a vibrator tip which is coupled with an ossicle (middle ear bone). It receives electrical signals from the implanted sound processor/microphone (via wired connection), and converts the signals back to audio frequencies which are sent to the vibrator tip for the transmission of vibrations to the middle ear bones to activate the auditory pathway.

Sterilization Methods

Method

Contacts

PhoneEmail
+82448629134qa2@hlbbio.co.kr

Regulatory Flags

DUNS number
987587913
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809262393927Sterilized Eol Lancet PlusHCG LANCET 28G2025-08-20
08809262393934Sterilized Eol Lancet PlusHCG LANCET 30G2025-08-20
08809262393873Sterilized Eol Auto LancetLBAL 26G2025-08-20
08809262393897Sterilized Eol Auto LancetLBAL 30G2025-08-20
08809262393910Sterilized Eol Lancet PlusHCG LANCET 26G2025-08-20
08809262393743SureComfort Safety LancetLBAL 30G2025-08-20

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00843484108356Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
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04719893237139TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
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